Computer System Validation (CSV) Engineer
3 days ago
Key Responsibilities:Develop and review validation plans, protocols (IQ, OQ,
PQ), and reports for computerized systems.Perform risk assessments a.....
Key Responsibilities:
- Develop and review validation plans, protocols (IQ, OQ,
PQ), and reports for computerized systems.
- Perform risk assessments and impact analysis related to
system validation.
- Ensure compliance with regulatory guidelines such as
FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Collaborate with IT, Quality Assurance, and
Manufacturing teams to support system qualification and validation
activities.
- Manage change control and deviation investigations
related to validated systems.
- Support audits and inspections by regulatory
authorities.
- Maintain validation documentation and ensure
traceability throughout the system lifecycle.
Qualifications:
- Bachelor’s degree in Pharmacy, Life Sciences,
Engineering, Computer Science, or related field.
- 5-8 years of experience in CSV within pharmaceutical
manufacturing or related regulated industries.
- Strong knowledge of GxP regulations, 21 CFR Part 11,
Annex 11, and GAMP 5 guidelines.
- Experience with validation of PLC SCADA, MES, or other
pharma manufacturing Automation systems.
- Excellent documentation and communication skills.
- Ability to work independently and in cross-functional
teams.
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